Manufacturer registered with FDA
SFS Group Hungary Kft.
Janossomorja, Hungary. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 1
- 510(k) clearances
- 0as applicant
- Markets registered in
- 325 registrations outside the US
- Establishments
- 1Hungary
Registered in 3 markets
Where regulators' registries name SFS Group Hungary Kft. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | SFS Group Hungary Kft. | 1 device types | — | Below |
| Colombia | INVIMA | Manufacturer | SFS GROUP HUNGARY KFT. | 24 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | SFS Group Hungary Kft. | 1 | 2025–2025 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What SFS Group Hungary Kft. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Dental Retractor AccessoriesEIF · Class 1 | Dental hand instruments | Maker | OptraGate | 2024 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| SFS GROUP HUNGARY KFT.FDA reg. 3030470653 | Janossomorja Gyor-Moson-Sopron, Hungary | Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10089926). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.